Racial Disparities in Clinical Trials

"...[The Gifford report in this week's New England Journal of Medicine] has important implications for the care of people with HIV infection and the representation of minority groups in clinical trials. Much of the improvement in outcomes for patients with HIV infection resulted from the widespread use, after 1996, of highly active antiretroviral therapy. Remarkably, by 1998, 90 percent of HIV-infected patients with private insurance and 79 percent of patients without health insurance had received such therapy. Despite these encouraging data, Gifford and colleagues show that black race and Hispanic or 'other' ethnic background negatively influenced access to clinical trials. This disparity persisted in their study even for blacks who tried to get experimental medications.

"Moreover, providers who were experienced in the treatment of HIV infection (and were therefore most likely to be involved in or to know about clinical trials) cared for most of the patients in this cohort....

"Why are minority groups underrepresented in clinical trials of treatments for HIV infection? There are barriers at the levels of the patient, the physician, the institution, and the community.

"...Physicians need to recognize and accept the fact that despite their desire to view each patient objectively and to base decision-making on biomedical information about that patient, it is often impossible to meet this goal. Limited data suggest that health care providers, like the rest of society, harbor prejudicial attitudes (biases or stereotyping) toward minority groups -- particularly blacks. Furthermore, these attitudes may influence a provider's decisions about treatment. Patients often respond to such attitudes with mistrust of the physician and reluctance to comply with treatment. This dynamic is particularly important in the informed-consent process (designed to inform patients of the risks and benefits associated with participation in a clinical trial and to facilitate self-determination), during which a lack of trust often leads to the patient's refusal to enter a clinical trial. Many blacks view signing the informed- consent document as relinquishing their autonomy and providing legal protection for the physician or the institution.

"Breaches of trust on the part of the patient or the physician appear to be a major factor contributing to disparities in the care provided to members of racial and ethnic minority groups. Health care workers who exhibit humane qualities (e.g., compassion, empathy, and honesty) and communicate in a respectful and culturally appropriate manner foster trust....

"The failure of drugs due to viral resistance is a common and serious problem in antiretroviral therapy. The consistency of adherence to highly active antiretroviral therapy predicts the biologic outcomes for HIV-infected persons in clinical trials. Pharmaceutical companies, as part of their efforts to obtain licensing approval, perform most trials of anti-HIV drugs. Consequently, researchers purposely avoid recruiting marginalized populations (such as members of minority groups, substance abusers, or homeless persons) to clinical trials because they believe that poor compliance is common in these groups. Many obstacles to participation by such patients (e.g., homelessness, lack of transportation, limited income, lack of child care, and active drug use) are probably surmountable and, more important, in many studies have not predicted poor compliance. ...However, most clinical trials are not designed to deal with these issues, so the population involved in studies rarely mirrors the full spectrum of patients who are likely to receive the treatment. As a result, many trials of antiretroviral drugs do not provide information on how to use the medications in routine clinical practice.

"Finally, investigators have a narrow view of the sort of person who makes a good participant in an HIV-related clinical trial: a white, college-educated, employed, housed, homosexual man. As a result, they have a more difficult time recruiting patients for such trials. In part, recruitment is difficult because many drugs are already available, combination therapy works, and the health of HIV-infected patients is improving. Many patients are reluctant to enroll in new trials, and their physicians, many of whom have a 'let's wait and see' attitude, do little to encourage them. But the battle is far from over. The scientific and health care communities must continue aggressive efforts to educate patients with HIV infection about clinical trials and to motivate and encourage them to participate in such trials. In order to provide generalizable results, trials must involve men and women, both homosexual and heterosexual, of all racial and ethnic groups, irrespective of their financial circumstances."

Talmadge E. King Jr., M.D., is affiliated with San Francisco General Hospital.

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